A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants☆
Section snippets
Methods
Between January 1999 and August 2000, mother-infant dyads were approached in the regional postpartum unit in St John's, Newfoundland, for informed consent to enter this study. The primary requisite for inclusion was an intent to breast-feed exclusively (with no more than one supplemental feed per day for at least 4 months), as per recommendations.11 Exclusion criteria included gestation <37 weeks, birth weight <2.5 kg, multiple pregnancy, major illness requiring intensive care admission, and
Results
Both groups were similar at study entry (1 month) with respect to birth weight, gestation, length, head circumference, and HGB and FRT levels (Table I, Table II). No significant difference was noted between treatment and placebo groups in maternal (52±16 vs 55±20) or paternal (50±15 vs 51±13) socioeconomic status, maternal age (31±4 vs 31±4 years), number of children in the household (1.6±0.7 vs 1.7±0.7), or maternal prepregnancy weight (151±30 vs 138±24 lbs).
Discussion
Our data suggest that iron supplementation of exclusively breast-fed term infants prevents the natural fall in HGB that occurs from 1 to 6 months of age. These results are similar to those reported in Swedish and Honduran infants given iron supplements from 4 to 6 months of age.13 In the current study, breast-fed infants who received iron demonstrated improved PDI and visual acuity at 13 months of age. Results for growth between groups in the current study did not differ at any time in contrast
Acknowledgements
We acknowledge the families and children who volunteered for the study; Renu Gill, Pharmacist, and the Pharmacy of the Janeway Children's Health and Rehabilitation Center, St John's, Newfoundland; Claude Mercer and Allison McDonald, Research Assistants; the Child and Women's Health Programs and Laboratory Staff of the Health Care Corporation of St John's; the Janeway and General Hospital Foundations, St John's, Newfoundland.
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Supported by the Canadian Institutes of Health Research and the Janeway Research Foundation.
There was no potential, perceived, or real conflict of interest in this study.